510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K913604Substantially Equivalent

Somatosensory Stimulus System

Biomagnetic Technologies, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913604 is the FDA 510(k) clearance record for SOMATOSENSORY STIMULUS SYSTEM, a class II device, cleared for Biomagnetic Technologies, Inc. on under FDA product code GZP (Stimulator, Mechanical, Evoked Response). FDA records list 8 510(k) clearances for Biomagnetic Technologies, Inc., from to . As of , FDA records show no recalls naming K913604.

Clearance record

Decision date
Received
(117 days to decision)
Product code
GZP Stimulator, Mechanical, Evoked Response
Regulation
21 CFR 882.1880
Device class
Class II
Review panel
Neurology
Applicant
Biomagnetic Technologies, Inc. 9727 Pacific Heights Blvd., San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code GZP

Trailing 12 months

FDA records hold no clearances under product code GZP in the trailing twelve months.

FDA records show no clearances under product code GZP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GZP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260